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Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block

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ClinicalTrials.gov Identifier: NCT01177423
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia.

The aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.


Condition or disease Intervention/treatment Phase
Dental Pain Procedure: Dental anesthesia Not Applicable

Detailed Description:

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection. Failure rate of local anesthesia highly increases with irreversible pulpitis or inflamed periradicular tissue.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia (from teeth 35 up to 38 and from 45 up to 48).

The primary aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Four clinical situations are evaluated : pulpitis; periapical abcess; pulpal hyperemia; asymptomatic decayed tooth.

Evaluated parameters are : speed of sedation, ability of cure, additional anesthesia needed, total of needles and cartridges used, side effects. Time and validation of complete anesthesia is controlled by pulp tester.

Studied population is patients cared in restorative, endodontics department.

Pulpal and periapical molar and premolar sedation is randomly managed by inferior alveolar nerve block or Quicksleeper intraosseous anesthesia, among studied population (divided in 2 groups of 50 patients). Pulp-tester measures anesthesia minute by minute.

The comparison of study results to bibliography, guidelines and advantages for using mechanical Quicksleeper anesthesia system will be discussed.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
Study Start Date : October 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Quicksleeper intraosseous anesthesia
Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.
 Procedure: Dental anesthesia
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
Active Comparator: Inferior alveolar nerve block
Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.
 Procedure: Dental anesthesia
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Irreversible pulpitis on second mandibular premolar or mandibular molars
  • Necessity of pulpotomy or pulpectomy

Exclusion Criteria:

  • Pregnancy, chest feeding
  • Non dental emergency state
  • hypersensibility to local anesthesia
  • Pheochromocytoma
  • Irregularity of cardiac rhythm
  • Myocardial infarct in the 6 previous months
  • Hepatic porphyria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177423


Locations
France
Assistance Publique - Hôpitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Herve TASSERY Assistance Publique-Hôpitaux de Marseille
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01177423     History of Changes
Other Study ID Numbers: 2009-08
2009-A00684-53
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:
restorative odontology
Patients cared in restorative odontology department

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs